Kind of contract
The mission of Corporate QA Compliance Specialist is to ensure that all the compliance activities are effectively and efficiently organized, planned and delivered with particular attention to the requirements of FDA QSR 21CFR Part 820, IVD-MD 98/79/EC Directive, IVD REGULATION (EU) 2017/746, ISO 13485 (including MDSAP approach) and ISO 9001
The Corporate QA Compliance Specialist works individually or as part of the team, responsible at Corporate level for:
a) conducting Internal Quality audits, in order to verify that all the QS requirements and procedures are correctly implemented and respected within the DiaSorin Group (he/she may audit departments, systems, products, processes, documents) and monitoring the CAPA Plans, if any.
b) conducting Quality audits at Corporate Suppliers and monitoring the CAPA Plans, if any.
c) Monitoring the effective compliance of the DiaSorin sites and affiliates to the applicable FDA, ISO, IVD MD Directive and Regulation 2017/476 requirements, also through the review of technical documents.
d) Supporting DS sites concerning Validation Activities, readiness of inspection programs, GMP requirements implementation
e) Acting as independent reviewer in design or changes HW and SW activities to ensure compliance of project documentation, guaranteeing the adequateness and the fulfillment of Analyzers HW&SW projects.
f) providing technical support for Regulatory assessments related to IVD MD Directive and Regulation 2017/476 about analyzers.
Qualifications Experience Personal Strengths Mobility
A minimum of 2-3 years’ work experience in a quality or regulatory role in the pharmaceutical, healthcare or medical device/IVD sector essential, preferably in an FDA regulated environment
Knowledge of relevant IVD medical device technologies and related design and manufacturing processes, knowledge of Quality Management System and current International and European regulations/standards to respect to IVD MD.
Personal characteristics: integrity, ethics, confidentiality, sincerity, diplomacy, open-mind, sense of observation, perspicacious, persevering, resolute, self-confident.
Abilities: excellent attention to detail and organization skills, ability to work equally as well on your own as in a team, excellent interpersonal skills, be organized and flexible, excellent written and verbal communication skills, ability to work under pressure and meet tight deadlines, good problem solving and decision making.
Computer skills: seasoned experience using Microsoft Excel, Word, PowerPoint.
Induction Program once hired
As for Company Policy